Omega 6:Omega 3 Ratio and Progression of Age-related Macular Degeneration (AMD).

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by University of Alberta
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Yves Sauve, University of Alberta
ClinicalTrials.gov Identifier:
NCT00987129
First received: September 29, 2009
Last updated: August 26, 2012
Last verified: August 2012
  Purpose

Docosahexaenoic acid (DHA) supplementation has been shown to prevent specific age-related changes in the retina through biochemical and functional evaluations, but it is unclear whether increased DHA intake-reflected through elevated DHA+EPA blood levels-can affect the natural history and progression of age-related macular degeneration (AMD). AMD is a disease affecting the macula, the part of the eye containing cone photoreceptors at the center of the visual field. The macula is responsible for vision in most daily functions, including reading, seeing fine details, and colour recognition. Severe AMD can lead to a central scotoma, severely impairing daily functioning. AMD can be divided into two forms: the more severe wet AMD, consisting of proliferation of new blood vessels in the retina, and dry AMD characterized by the development of drusen, a buildup of extracellular material . The investigators are focused on the group with the highest risk of developing the two advanced forms of AMD [wet AMD or central geographic atrophy]: patients with unilateral wet AMD and dry AMD in their other eye. The study will consist of following up a cohort of such subjects and monitoring their visual function in a comprehensive manner. Working in concert with clinical ophthalmologists and basic scientists, the investigators will monitor "DHA+EPA" and "Omega6:Omega3 fatty acid ratio" levels in the blood, inherited predispositions through genetic analysis, lipofuscin (an accumulated waste product) levels & AMD progression via fundus photography, visual acuity, and retinal function via full-field and multifocal electroretinograms. These different factors will be cross-correlated and evaluated to determine how omega-3 fatty acids affect the progression of AMD.


Condition Phase
Age-related Macular Degeneration
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Omega-6:Omega-3 Fatty Acid Ratio on Delaying Progression of Age-related Macular Degeneration (AMD) in Moderate to High Risk Individuals.

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Progression of dry AMD status according to international classification/grading system. [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Delayed progression to neovascular AMD (NVAMD) or Central Geographic Atrophy (cGA) in the fellow eye. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood for genotyping and measuring omega-3 FA status. Serum for Cytokine level analysis.


Estimated Enrollment: 200
Study Start Date: March 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Men and women with Neovascular (wet) AMD in one eye and early or intermediate dry AMD in the fellow eye, taking AREDS vitamins (or equivalent).

Criteria

Inclusion Criteria:

  • 50+ years of age
  • NVAMD (Wet) in one eye, early or intermediate dry-AMD in the fellow eye
  • taking AREDS vitamins (or equivalent)

Exclusion Criteria:

  • Central geographic atrophy
  • Diabetic retinopathy
  • Ocular surgery in the eye with dry-AMD (not including cataract IOL surgery)
  • Underlying ocular pathology in the eye with dry-AMD (especially glaucoma, dense cataracts, and retinitis pigmentosa)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00987129

Contacts
Contact: Ioannis Dimopoulos, MD 780-4929596 dimopoul@ualberta.ca

Locations
Canada, Alberta
Alberta Retina Consultants Recruiting
Edmonton, Alberta, Canada, T5H 0X5
Contact: Matthew Tennant, MD    (780) 448-1801    mtennant@ualberta.ca   
Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada, T5H 3V9
Contact: Ian MacDonald, MD    780-4929596    macdonal@ualberta.ca   
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2H7
Contact: Ioannis Dimopoulos, MD    780-4929596    dimopoul@ualberta.ca   
Sponsors and Collaborators
Yves Sauve
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Yves Sauvé, PhD Department of Ophthalmology
  More Information

Publications:

Responsible Party: Yves Sauve, PhD, AHFMR Senior Scholar, Ophthalmology Assistant Professor, University of Alberta, University of Alberta
ClinicalTrials.gov Identifier: NCT00987129     History of Changes
Other Study ID Numbers: MOP 79278, 200809MOP-192321, CIA-CBAA-27683
Study First Received: September 29, 2009
Last Updated: August 26, 2012
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
DHA
EPA
AMD
drusen
omega-3 fatty acids
omega6:omega3 ratio

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 20, 2014